VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is
FDA device recall Z-2064-2019 · posted 2019-08-12 · Terminated
Recall details
- Recalling firm
- Fenwal Inc
- Reason for recall
- The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
- Action taken
- The firm initiated the recall by letter on 06/24/2019. The letter describes the issues and provided supplemental instructions to be implemented until the new software is installed. The firm issued a press release on 06/28/2019.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 9461 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2019-06-24
- Date posted
- 2019-08-12
- Date terminated
- 2023-03-06
- Location
- Lake Zurich, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILIA INFUSION SYSTEM (K121613) | Fresenius Kabi AG | 2013-05-01 |